Esketamine Approved for Treatment-Resistant Depression

MJ_Prototype via Getty Images

Ben Pena
|
12 March, 2019, 17:55

The agency hopes that the new drug will benefit those who find no relief from antidepressants now available in the market. Spravato is meant to treat patients who have major depressive disorder (MDD) and have not responded "adequately" to two at least two different types of antidepressants.

The new drug from Johnson & Johnson acts on different brain chemicals than decades-old antidepressants like Prozac. In comparison, many antidepressants now available can take weeks, or even months, to have an effect. The nasal spray is a mirror image of the chemical "anesthetic ketamine", popular as a recreational party drug, which is known locally as the "Special K".

A variant of the party drug Ketamine has been licensed in the U.S. for treatment-resistant depression. J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive.

Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness.

Turner serves on the FDA advisory committee that recommended last month that the FDA approve esketamine, but didn't take part in that meeting.

The ketamine-like drug is the first of several psychoactive substances making their way through the US regulatory process as physicians search further afield for new therapies.

"My concern is that we don't really how it gets people un-depressed", Mark George, MD, a psychiatrist and neurologist at the Medical University of SC in Charleston, tells Health.

The FDA approval is a significant milestone not only for the company but for those living with MDD. The drug's labeling will also warn about the risks of misuse, abuse, and possible suicidal thoughts.

Clinical trials suggest it is up to 10 times more effective than current drugs in people suffering from treatment-resistant depression.

Unlike ketamine, psilocybin and MDMA have no legal medical use. Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said. "It really has opened up a whole new way of thinking about depression", Gerard Sanacora, professor of psychiatry at Yale University School of Medicine and director of the Yale Depression Research Program, said of ketamine. He said the approval legitimizes the approach he and other doctors have been taking. It did not, however, reveal the drug's list price. At two sessions a week, the cost is upwards of $4,720 in the first month.

All Tesla sales will still be conducted online, and the showrooms will remain to show clients how to order a Tesla on their phone. As part of that settlement, Musk stepped down as the company's chairman and he and Tesla agreed to pay $20 million each in fines.

Taking place at Steve Job Theater in the company's Cupertino HQ, the event will take place at 1 AM Malaysian time on 26 March. It would be competing directly with the widely popular services like Netflix, Hulu, Amazon Prime, etc.

That night will be seen as one of the great European exploits in United's history - all thanks to Marcus Rashford's late penalty. Speaking at his post-match news conference on Sunday afternoon, Emery said: "I'm very proud of our players".

Algerian president Abdul Aziz Bouteflika will not be seeking a fifth term, the presidency confirmed late Monday. Celebrations popped up instead of protests on the streets of the capital, Algiers, at the news.

Toronto is the second team in the league to have clinched a postseason spot, while Milwaukee was the first. The Raptors have won the first two games of this current three-stop road trip by an average of 22 points.

Passing good friend, D'Angelo Russell, as the youngest National Basketball Association player to score 500 three-pointers. Beyond that, they've gone 6-29 in road games and Phoenix was a 17-point underdog when the line went off the board.

Somewhere between Mad Max and Overwatch , Octane should really shake up the meta of the highly successful battle royale. The footage comes from a user on the dedicated Apex Legends Reddit community, who offered some gameplay video pre-game.

When asked for the third time on the matter, Sanders responded again by saying, "You ought to ask the Democrats". The Democrats have become an anti-Israel party; they've become an anti-Jewish party, and that's too bad.

German intel sharing at risk over Huawei spat
However, Germany does not appear swayed by the US' arguments against Huawei, and plans to allow Huawei to bid for the project. Also on rt.com U.S. advises Italy to steer clear of China's new Silk Road... because it's a National Security issue?

Mother accused of stabbing daughter to death
Police say Rivera first pounded on the door of a home at 7:30 am and accused a man there of having sex with her daughter. When asked if she had more injuries, she said that she had killed her daughter and that " my baby is gone ".

Marco Silva charged by FA over Newcastle confrontation
One of Pep Guardiola's team often finds themselves in the team, but the same can't be said for Rafael Benitez's men. The Portuguese was furious with the decision to let Ayoze Perez's late victor stand amid suspicions of offside.

Chiefs to sign former Texans safety Tyrann Mathieu
Jackson, a fan favorite and highly respected inside the Texans' locker room, reportedly received a three-year, $33 million deal. Mathieu earned notoriety during college at LSU for his ability to create turnovers, earning the nickname "Honey Badger".